Project Manager, Regulatory Affairs

Project Manager, Regulatory Affairs

Contract Term: Anticipated 1 year

THIS IS PART TIME: Anticipated 30 hours a week

Location: Bergen County NJ

This is a great opportunity to contribute your Project Management skills and knowledge of regulatory activities and submissions to this global Pharmaceutical firm.

  • Must be knowledgeable in domestic and international regulatory guidelines, policies and regulations; GxPs (GCPs, GLPs, GMPs; regulatory agency structure, processes and key personnel; submission/registration types and requirements
  • At least 4 years Life Science industry experience, of which 2 years in regulatory or project management
  • PMP a PLUS!

Essential Duties

  • Manage multiple projects while ensure timely completion of tasks and overall completion
  • Manage IND and NDA project deliverables and timelines
  • Maintain timelines for components of regulatory deliverables
  • Conduct meetings with internal teams, collaborators, as needed, including meeting agendas, minutes, action items
  • Provide day-to-day department support activities to aide completion of project deliverables
  • Communicate program and project plans to ensure a common understanding by stakeholders and team members
  • Participates in cross-functional teams in support of continuous improvement and other management objectives
  • Execute project management operational activities in accordance with approved operating plans and procedures
  • Monitor applications under regulatory review
  • Communicate application progress to internal stakeholders
  • Track appropriate HA responses to ensure timely submission to regulatory authorities
  • Track and maintain timelines for regulatory activities and submissions.
  • Track regulatory commitments and timelines for maintenance activities such as Post-marketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines

 

Qualifications:

  • BS or BA in a related field
  • At least 4 years Life Science industry experience, of which 2 years in regulatory or project management
  • Project management and organizational skills. Experience in the use and understanding of the critical value of technology in planning, managing milestones and integrating interdependencies within an organization.
  • MS project experience required.
  • PMP certification a plus.
  • Ability to work in a virtual setting/across time-zones, (i.e., making effective use of communication tools- WebEx, and video conferencing, etc.)
  • Strong planning and organizational skills
  • Well-developed analytical and problem solving skills
  • Knowledgeable in domestic and international regulatory guidelines, policies and regulations; GxPs (GCPs, GLPs, GMPs; regulatory agency structure, processes and key personnel; submission/registration types and requirements
  • Ability to effectively work with teams and promote collaborations in a matrix organization.
  • Excellent verbal and written communication skills, ability to interact with all levels of management within the organization and to external business contacts.
  • Accepted file types: doc, pdf, txt, docx.